Kornimate/medical-research-clean huggingface dataset:
aggressive cholesterol therapy to inhibit vein graft events after cabg (active trial)

Conditions: Saphenous Vein Graft Disease

Summary: during coronary artery bypass graft surgery (cabg), saphenous vein from the leg is used to bypass the atherosclerotic blockages in the arteries of the heart. unfortunately, vein bypasses themselves develop blockages over time, a process termed saphenous vein graft disease. by lowering cholesterol levels in the blood, statin medications are used after surgery to prevent the development of atherosclerotic blockages in the vein bypasses. recently, higher doses of statin medications have been introduced, with some studies showing that they are more effective than traditional doses when used in heart attack patients. furthermore, laboratory tests have shown that higher doses of statin medications can slow the development of atherosclerosis. despite these benefits, very little is known regarding the use of high-dose statin therapy after bypass surgery in humans. the goal of this study will be to see if high-dose statin therapy will prevent the development of vein graft occlusion during the first year after bypass surgery. patients will be randomized to receive either high-dose statin therapy or conventional moderate-dose statin therapy starting within 4 days of surgery and continuing for the duration of one year after the operation. the statin medication will be given in capsule form. during the course of this study, neither the patient nor the health care team will know which treatment each patient is receiving. one year after bypass surgery, a computed tomography (ct) coronary angiogram will be performed to evaluate the patency of the vein bypasses.

the current clinical guidelines recommend treatment to achieve ldl levels \<100 mg/dl after surgical coronary revascularization. however, recent studies have illustrated that even more intensive lipid reduction with high-dose statins can further improve cardiovascular outcomes. targeting ldl levels to 70 mg/dl after cabg with intensive statin therapy may prevent the process of postoperative saphenous vein graft disease and lead to improved graft patency. therefore, in the active trial, we will conduct a randomized controlled trial comparing high-dose (80 mg atorvastatin) to moderate-dose (10 mg atorvastatin)statin therapy in patients undergoing cabg with saphenous vein grafts. the effect of aggressive cholesterol therapy on the process of vein graft disease will be examined with computed tomography (ct) coronary angiography one year after cabg. this study will address the subject of postoperative high-dose statin therapy and help determine the optimal lipid-lowering strategy following cabg.

Eligibility criteria:
inclusion criteria: * patients undergoing first-time cabg with at least 1 saphenous vein graft exclusion criteria: * redo-cabg * statin allergy * severe renal dysfunction * severe liver disease

Keywords: statin, cabg, saphenous vein graft, graft occlusion, lipids
diffusion tensor imaging to judge the prognosis of patients with diffuse axonal injury

Conditions: Diffuse Axonal Injury

Summary: the investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with dti(diffusion tensor imaging). the investigators then determine the fa（fractional anisotropy）value and the adc(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the fa（fractional anisotropy）value and adc(apparent diffusion coefficient) value and gcs(glasgow coma scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.by using fiber tractography the investigators can have the extent of recovery of the patient of dai（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).

the investigators will examine 15 patients who was firstly diagnosed as diffuse axonal injury and 15 patients negative for magnetic resonance examination with no trauma with dti(diffusion tensor imaging). the investigators then determine the fa（fractional anisotropy）value and the adc(apparent diffusion coefficient) value of relational interesting area（corpus callosum、brainstem、basal ganglia）to analyse the correlation between the fa（fractional anisotropy）value and adc(apparent diffusion coefficient) value and gcs(glasgow coma scale) and coma time,so that the investigators can quantify the damage degree of patients' white matter fiber.at the same time the investigators rebuild the white matter fiber tract(corpus callosum 、corticospinal tract、optic radiation) of patients using diffusion tensor tractography so that the investigators can judge intuitively the extent of damage and recovery. the investigators trace the repair of nerve fibers after treatment and guide the further treatment.this trial can exactly determine the relationship between the fa（fractional anisotropy）value and adc(apparent diffusion coefficient) value in relational interesting area and the extent of damage in patient of dai（diffuse axonal injury）.meanwhile the trial confirms that the dti(diffusion tensor imaging) can exactly judge the prognosis of dai（diffuse axonal injury）.obviously by using fiber tractography the investigators can have the extent of recovery of the patient of dai（diffuse axonal injury） in real-time detection and give guidance for the clinical decision and the judgement of prognosis).

Eligibility criteria:
inclusion criteria: * has a history of trauma exactly * immediate coma after injury * increased intracranial pressure level do not agree with clinical illness severity * no significant changes of ct while with severe clinical manifestations exclusion criteria: * none
prospective real world study on therapy prediction algorithm training

Conditions: Stress; Emotional Wellbeing

Summary: this study examines the impact of using an algorithm to select therapy content for patients engaged with the mobile mental health platform amdtx (mobio interactive). the algorithm is to be trained with three separate sources of data. two sources of data come from self-reports by the patients themselves, provided before and after engaging with therapy content. the third source of data comes from an objective measurement of psychological stress, made possible through artificial analysis of computer vision data captured from the mobile device camera as the patient completes a 30 second selfie video before and after engaging with therapy content.

from 2,786 unique individuals engaging between march 2015 and december 2022 in english language psychotherapy sessions and providing pre- and post-session self-report and facial biometric data via the amdtx mental health platform (mobio interactive pte ltd, singapore), analysis was conducted on 67 "super users" that completed at least 28 sessions with all pre- and post-session measures. amdtx is a clinically validated mental health platform that provides patients with audio recordings supporting mental wellbeing (asynchronous and on-demand psychotherapy). amdtx also contains easy to use tools that rapidly assess mental wellbeing, including an objective measure of psychological stress derived from ai analysis of facial biomarkers (objective stress level; ∆osl), and ecological momentary assessments (emas). two commonly used emas within amdtx are self-reported stress (∆srs) and self-reported mood (∆srm). these three data sources were used to independently train an algorithm designed to predict what future therapy sessions would prove most efficacious for each individual. algorithm predictions were compared against the efficacy of the individual's self-selected sessions.

Eligibility criteria:
inclusion criteria: * completion of at least 28 english-language psychotherapy sessions that contained the required session payloads for algorithm inclusion, and only when the objective and two subjective measures were all completed both before and after each session. exclusion criteria: * under 18 years old

Keywords: precision psychiatry recommendation algorithm psychological stress remote therapy remote monitoring
post-resection treatment of large colon polyps

Conditions: Recurrence

Summary: patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (emr) of lesions 15mm and larger will be randomized to stsc (80 w, effect 5) vs apc (preferred settings) vs no treatment of the perimeter of the emr site.

data regarding polyp morphology, location \& shape will be recorded in addition to procedure and treatment length. injection fluid use and clipping will also be recorded in addition to any procedural complications. all randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. the investigators will measure the rate of recurrence by endoscopic visualization of the emr site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.

Eligibility criteria:
inclusion criteria: * 25 years and older * ability to provide informed consent * undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion exclusion criteria: * pedunculated lesions * inflammatory bowel disease * inability to provide informed consent * lesions less than 15mm in largest dimension

Keywords: argon plasma coagulation snare tip soft coagulation recurrence rates
germline brca1 and brca2 mutations in jewish women affected by breast cancer

Conditions: Breast Cancer

Summary: the purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific brca alleles (braca1 185delag and 5382insc; brca2 6174delt) among jewish women.


Eligibility criteria:
inclusion criteria: * patients are eligible for the study if they are over 18 years of age, identify their ancestry as jewish (both sephardic and ashkenazi jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent. * relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific brca1 or brca2 mutation if they are able to give informed consent.

Keywords: breast cancer jewish brca1 brca2 97-029
study on the development of opioid induced hyperalgesia (oih) after exposure to alfentanil

Conditions: Hyperalgesia

Summary: the purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.

this project investigates the phenomenon of opioid-induced hyperalgesia (oih). opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. this phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. it is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. this study investigated the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (n=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg intramuscular (im) per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (cpt), and mechanical quantitative sensory testing (mqst) each administered repeatedly over time within each testing day. the goal was to determine the time course of oih development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Eligibility criteria:
inclusion criteria: * age 18-55 * no active medical conditions * bmi between 20-30 * able and willing to perform/tolerate pain procedures * able to communicate in english exclusion criteria: * lifetime substance use disorder, except for alcohol abuse/dependence in remission * use of opiates in last 3 months * ongoing marijuana use * acute or chronic pain * neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia) * current use of prescribed or over the counter pain medications * previous adverse reaction to opiate medications or diphenhydramine * use of tobacco or caffeine on study days

Keywords: opioid induced hyperalgesia
stitch (simplified therapeutic intervention to control hypertension)

Conditions: Hypertension

Summary: the objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management.

there is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens. although decreasing the frequency of drug taking does improve blood pressure control, whether fixed-dose combinations are more effective than taking multiple tablets is unknown. additionally, notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension, the choices for practitioners in regards to first line therapy is widening (and may be more confusing, especially in the setting of the proliferation of recommendations for a range of diseases). whether a simplified treatment algorithm, consistent with the canadian hypertension education program (chep) guidelines but using a step-care approach, might improve management of hypertension is unknown. the current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy. this is a cluster randomized controlled trial. approximately 50 family practices eligible for study participation will be randomized in a 1:1 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension. the randomization schedule will be stratified by the year of graduation of the family physician (\< 1984 or ≥ 1984). within each practice, 50 subjects will be managed according to the algorithm or usual care and will be followed for six months.

Eligibility criteria:
inclusion criteria: * male or female subjects 18 years or older * hypertension sbp ≥ 140 mmhg or dbp ≥ 90 mmhg whether untreated or partially treated * absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease * not participating in other hypertension studies * ability to give informed consent

Keywords: hypertension family physicians fixed dose combination therapy cluster randomized controlled trial
virtual exercise rehabilitation treatment program for post exacerbation of chronic obstructive pulmonary disease

Conditions: COPD

Summary: respiratory rehabilitation is an intervention proven to improve quality of life in those with chronic lung disease but access remains poor. the investigators will assess the feasibility and acceptability of a virtual platform for respiratory rehabilitation as an alternative to in person rehabilitation. the aim is to use the technology in those post admission with copd where access has been even more of a challenge as during this period patients find it difficult to access an out patient program due to their frailty.

people living with lung disease struggle with activities. an exercise program can help but these programs are limited and are hard to get to and generally have a long wait list. the investigators will offer exercise and education through a tablet with internet provided 2 times per week for 10 weeks for patients admitted to hospital with a worsening of their copd. patients will work with a trained therapist for the exercise sessions and with the team for the education sessions. the investigators will assess outcomes on functional and quality of life improvements as well as feasibility and scalability of the technology.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years * maximum age of 90 years * diagnosis of copd exclusion criteria: * inability to perform exercise * severe debilitating conditions
oral nifedipine versus oral labetalol

Conditions: Severe Postpartum Hypertension

Summary: this study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.

hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. while the true incidence of postpartum hypertension is unknown, blood pressure (bp) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition. the american college of obstetricians and gynecologists (acog) recommends medical treatment of persistent postpartum hypertension, defined as systolic bp (sbp) ≥150 mmhg or diastolic bp (dbp) ≥100 mmhg, on two or more occasions 4-6 hours apart. prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. however, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared. our aim was to determine whether oral labetalol is associated with a shorter time to bp control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. our primary outcome was time to sustained bp control defined as the absence of severe hypertension (sbp ≥160 mmhg or dbp ≥105 mmhg) for at least 12 hours. secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years with the abililty to give informed consent * intrauterine pregnancy ≥ 32 weeks * postpartum * persistent postpartum blood pressures ≥ 160/105 on two or more occasions * primary obstetrician amenable to starting either study medication in the postpartum period exclusion criteria: * use of other oral antihypertensives concomitantly * known av heart block * hr \ 120 * absolute contraindication to nifedipine or labetolol such as allergy * significant renal disease (cr \>1.5 mg/dl) * heart failure * moderate persistent or severe asthma * preexisting diagnosis of chronic hypertension with medical treatment before delivery * chronic hypertension
characterization of biophysical stromal properties in human cancer: towards personalized computational oncology

Conditions: Carcinomatosis, Peritoneal; Pancreas Cancer; Ovarian Cancer; Colon Cancer

Summary: drug delivery in solid tumors, whether administered systemically or locoregionally, is hindered by an elevated interstitial fluid pressure (ifp). stromal targeting therapies are in active development, aiming to enhance drug transport after systemic or locoregional delivery. to date, no clinical methods are available to quantify tumor biophysical properties (including ifp). the investigators aim to use a combination of dynamic contrast enhanced mri and computational fluid modeling (cfd) to measure stromal ifp in patients with pancreatic cancer and in patients with ovarian or colonic peritoneal carcinomatosis (pc). computational data will be correlated with therapy response, platinum drug penetration, and invasively measured biophysical parameters after intravenous (pancreas) or intraperitoneal (ovarian/colonic pc) administration of a platinum compound. this would be the first in depth clinical study addressing this important topic, and could pave the way to developing personalized computational based treatment approaches aimed at targeting the biophysical environment of the tumor stroma in order to enhance cancer drug delivery.


Eligibility criteria:
inclusion criteria: * patients with non-cystic adenocarcinoma the pancreas requiring neoadjuvant chemotherapy (any) because of borderline resectability * patients with stage iiic or iva ovarian cancer planned for debulking and hipec. * patients with stage iiic or iva colorectal cancer planned for debulking and hipec exclusion criteria: * age \<18 years * pregnancy, or suspected inadequate contraception during study period * clinically detectable ascites * intestinal or urinary tract obstruction * hepatic and/or extra-abdominal metastatic disease * impaired renal function (serum creatinine \> 1.5mg/dl or calculated gfr (ckd-epi) \< 60ml/min/1.73 m²) * impaired liver function (serum total bilirubin \> 1.5 mg/dl, except for known gilbert's disease) * platelet count \< 100.000/µl * hemoglobin \< 9g/dl * neutrophil granulocytes \< 1.500/ml * irresectable or metastatic disease * contra-indication for contrast enhanced mri * known allergy or intolerance to gadolinium based contrast agents * severe claustrophobia * patients with metallic foreign bodies (pacemaker, neurostimulator, pedicle screw, cerebral aneurysm clips...) that may dislodge in a strong magnetic field * frail and medically unfit patients (karnofsky index \< 60% and who performance score 3 or 4) * estimated life expectancy \< 12 months * in case of ovarian/colon cancer: no visible peritoneal metastasis on ct scan * acute or chronic pancreatitis
safety and tolerability of clobazam as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with dravet syndrome

Conditions: Dravet Syndrome

Summary: to investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with dravet syndrome.


Eligibility criteria:
the inclusion and exclusion criteria for the patients who participated in lead-in study 14362a will be transferred from the 14362a study and for the patients who did not participate in lead-in study 14362a the inclusion/exclusion is separately listed below. inclusion criteria: 1. the patient has a diagnosis of dravet syndrome supported by: 1. onset of seizures in the first year of life 2. history of fever-induced prolonged seizures as determined by the investigator * these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures 3. multiple seizure types which may include: * generalised tonic-clonic (required for inclusion) * clonic (required for inclusion) * myoclonic jerks/seizures 4. history of normal development prior to seizure onset followed by development delay or regression after seizure onset 5. abnormal eeg consistent with dravet syndrome 2. the patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months other protocol-defined inclusion and exclusion criteria may apply.